On 12th February, Roche announced detailed results from four Phase 3 studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). All four studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. Results from the studies will be presented at a medical symposium Angiogenesis, Exudation, and Degeneration 2021.
Diabetic macular edema (DME) is a vision-threatening complication of diabetic retinopathy (DR) that can lead to blindness and affects ~ 21 million people globally. DR occurs when blood vessel damage causes blood and/or fluid to leak into the retina. This leads to swelling and blockage of blood supply and becomes DME when the swelling occurs in the macula – the central area of the retina responsible for sharp vision. The number of people with DME is expected to grow alongside the prevalence of diabetes.
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or “wet” AMD (nAMD) is an advanced form of disease that can cause rapid and severe vision loss. It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding, and/or fibrosis. Globally, approximately 20 million people live with nAMD, and the condition will become more prevalent as the global population ages.
Faricimab is a bispecific antibody designed for the eye. It blocks both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways and reduces blood leaking. Through this novel mechanism of action, faricimab reduces inflammation and leakage more than inhibiting either pathway alone. This may improve vision outcomes for longer than with anti-VEGF monotherapy, and in turn, reduce the frequency of eye injections needed.
The Clinical Trials
All clinical trials compared faricimab usage to that of aflibercept. YOSEMITE (NCT03622580) and RHINE (NCT03622593) evaluated the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema. The studies in DME assessed two dosing regimens of faricimab given every two months or at personalized treatment intervals (PTI) of up to four months compared to every two months for aflibercept. Both studies met their primary endpoint, with faricimab consistently shown to offer visual acuity gains equal to aflibercept.
The TENAYA (NCT03823287) and LUCERNE (NCT03823300) studies in nAMD assessed faricimab given at fixed intervals of every two, three, or four months compared to aflibercept given every two months. Both studies met their primary endpoint, with faricimab consistently shown to offer non-inferior visual acuity gains to aflibercept. In TENAYA and LUCERNE, the average vision gains from baseline in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms. These trials were done on 1,329 people living with nAMD (671 in TENAYA and 658 in LUCERNE).
DME and AMD affect an increasing number of people and have a marked negative effect on individual quality of life. Despite this, there are difficulties getting patients to submit to regular injections in the eye. Knowing this, the success of these trials and the ability to only get a needle in one’s eye every four months is a great leap forward and likely to encourage getting treatment.
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